Combination Therapy With Intravenous VSV-IFN?-NIS and Pembrolizumab in Refractory NSCLC and HNSCC
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 23
Summary
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Non -Small Cell Lung Cancer
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Three patients will initially be treated at each dose level. The dose of each subsequent dose level will be determined by the adverse event (AE) evaluations. The VSV-IFN?-NIS starting dose will be 1.7 x 10e10 TCID50 injected intravenously. If this dose level is tolerated (no more than 1 out of 6 or ...
Three patients will initially be treated at each dose level. The dose of each subsequent dose level will be determined by the adverse event (AE) evaluations. The VSV-IFN?-NIS starting dose will be 1.7 x 10e10 TCID50 injected intravenously. If this dose level is tolerated (no more than 1 out of 6 or 0 out of 3 patients experience DLT), a second dose level may be tested (5 × 1010); if this dose is tolerated it will be the dose for parts B and C. If ? 2 DLTs are seen in 6 patients at a given dose level, the level below will be explored using the same criteria.
Tracking Information
- NCT #
- NCT03647163
- Collaborators
- Mayo Clinic
- Investigators
- Principal Investigator: Alex Adjei, MD, PhD Mayo Clinic
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